FDA Adverse Event
Injury
Summary report: N
AMISTEM COLLARED STEM, HA COATED STEM SIZE 2 STD
MDR report key: 6819951
·
Received August 25, 2017
Report
- Report Number
- 3005180920-2017-00468
- Event Type
- Injury
- Date Received
- August 25, 2017
- Date of Event
- July 26, 2017
- Report Date
- August 25, 2017
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- LZO
- UDI-DI
- 07630030804571
- PMA / PMN Number
- K121011
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
BATCH REVIEW PERFORMED ON 21 AUGUST 2017. LOT 140728: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 31 MARCH 2014. EXPIRATION DATE: 2019-02-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.
Description of Event or Problem · 1
THE PATIENT CAME IN COMPLAINING OF INSTABILITY. THERE WAS NO BONE GROWTH ON THE IMPLANT WHICH CAUSED THE INSTABILITY. THE SURGEON REVISED THE STEM AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS ARE AVAILABLE. EXPLANTS ARE NOT AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 601837 | AMISTEM COLLARED STEM, HA COATED STEM SIZE 2 STD | CEMENTLESS FEMORAL STEM | LZO | MEDACTA INTERNATIONAL SA | 140728 | 07630030804571 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Required Intervention |